Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT04718935
Brief Summary:
To identify nutritional and metabolic biomarkers that are related to the prognosis of traumatic brain injury patients, and to develop a prognosis prediction model using biomarkers
Study Objectives:
1. Establishment of a prospective registry for traumatic brain injury patients
2. Identification of nutritional and metabolic biomarkers related to prognosis of traumatic brain injury patients
3. Development of a prognosis prediction model using nutritional and metabolic biomarkers
4. Development of identification model for high-risk population of disabilities after traumatic brain injury
Detailed Description:
Study design: Multicenter observational cohort study, 5 tertiary teaching hospital emergency departments in Korea
Study period: July 2018 to December 2023 (66 months)
Study population: Traumatic brain injury patients aged over 18.
Cases will be consecutive adult patients with EMS-treated traumatic brain injury and transport to the 5 emergency departments of participating hospitals within 72 hours after the trauma and confirmed cerebral hemorrhage or diffuse axial injury by radiological examination. A prospective traumatic brain injury patient cohort will be developed and all survived traumatic brain injury cases will be followed at 1-month and 6-month after ED discharge by telephone.
During the study period, the investigators aim to recruit a total 1,200 cases (600 cases between July 2018 and June 2020, 600 cases between March 2021 and June 2023).
Data collection: Following data will be collected
Clinical data: Basic demographic and clinical outcomes will be retrieved from medical records.
Survey data: Comorbidity, symptom, result of neurologic examination, socioeconomic status (occupation, income etc) data will be collected.
Blood samples: The investigators aim to develop nutritional and metabolic biomarkers of traumatic brain injury. The investigators also plan to further develop traumatic brain injury biomarkers using proteomics.
Follow-ups: All survived traumatic brain injury cases will be followed-up at 1-month and 6-month after ED discharge and their survival, disability, and quality of life outcomes will be collected by telephone.
Ethics Statements: All 5 hospitals participating in the study were IRB approved(Seoul National University Hospital(IRB No: 1806-078-951), SMG-SNU Boramae Medical Center(IRB No: 30-2018-85), Kyungpook National University Hospital(IRB No: 2018-10-014-007), Chonnam National University Hospital(IRB No: CNUH-2018-297), Chungbuk National University Hospital(IRB No: 2018-09-018)). All study patients was registered in cohort after acquisition of consent.
Study:
NCT04718935
Study Brief:
Protocol Section:
NCT04718935